SAFETY DATA SHEET

Nomegestrol / Estradiol Formulation
Version
10.0

Revision Date:
2024/04/06

SDS Number:
17227-00024

Date of last issue: 2023/09/26
Date of first issue: 2014/09/30

1. PRODUCT AND COMPANY IDENTIFICATION
Chemical product name:

Nomegestrol / Estradiol Formulation

Supplier's company name, address and phone number
Company name of supplier: Organon & Co.
Address:

30 Hudson Street, 33nd floor
Jersey City, New Jersey, U.S.A 07302

Telephone:+1-551-430-6000

E-mail address:

EHSSTEWARD@organon.com

Emergency telephone number :+1-215-631-6999

Recommended use of the chemical and restrictions on use
Recommended use: Pharmaceutical
Restrictions on use: Not applicable

2. HAZARDS IDENTIFICATIONGHS classification of chemical product
Carcinogenicity: Category 1A
Reproductive toxicity:

Category 1ASpecific target organ toxicity repeated exposure:

Category 1 (Liver, Bone, Blood, Endocrine system)

Short-term (acute) aquatic
hazard:Category 3

Long-term (chronic) aquatic
hazard:Category 1

GHS label elements
Hazard pictograms:

Signal word:

DangerHazard statements:

H350 May cause cancer.
H360FD May damage fertility. May damage the unborn child.
H372 Causes damage to organs (Liver, Bone, Blood, Endo1 / 25

SAFETY DATA SHEET

Nomegestrol / Estradiol Formulation
Version
10.0

Revision Date:
2024/04/06

SDS Number:
17227-00024

Date of last issue: 2023/09/26
Date of first issue: 2014/09/30

crine system) through prolonged or repeated exposure.
H402 Harmful to aquatic life.
H410 Very toxic to aquatic life with long lasting effects.
Precautionary statements:

Prevention:
P201 Obtain special instructions before use.
P202 Do not handle until all safety precautions have been readand understood.
P260 Do not breathe dust.
P264 Wash skin thoroughly after handling.
P270 Do not eat, drink or smoke when using this product.
P273 Avoid release to the environment.
P280 Wear protective gloves/ protective clothing/ eye protection/ face protection.
Response:
P308 + P313 IF exposed or concerned: Get medical advice/attention.
P391 Collect spillage.
Storage:
P405 Store locked up.
Disposal:
P501 Dispose of contents/ container to an approved waste
disposal plant.

Other hazards which do not result in classification
Important symptoms and out- : Dust contact with the eyes can lead to mechanical irritation.
lines of the emergency asContact with dust can cause mechanical irritation or drying ofsumed
the skin.
May form explosive dust-air mixture during processing, handling or other means.
3. COMPOSITION/INFORMATION ON INGREDIENTS
Substance / Mixture:

MixtureComponents
Chemical name
Cellulose
Estradiol
17-Hydroxy-6-methyl-19norpregna-4,6-diene-3,20-dione17-acetate
Talc

CAS-No.
9004-34-6
50-28-2
58652-20-3

Concentration (% w/w)>= 10 - < 20>= 2.5 - < 10>= 1 - < 2.5

14807-96-6> 0 - < 10

1-468

Titanium dioxide

13463-67-7> 0 - < 10

1-558, 5-5225

Propylene glycol

57-55-6
2 / 25>= 0.1 - < 1

ENCS No.

2-234

SAFETY DATA SHEET

Nomegestrol / Estradiol Formulation
Version
10.0

Revision Date:
2024/04/06

SDS Number:
17227-00024

Date of last issue: 2023/09/26
Date of first issue: 2014/09/30

4. FIRST AID MEASURES
General advice:

If inhaled:

In case of skin contact:

In case of eye contact:

If swallowed:

Most important symptoms
and effects, both acute anddelayed:Protection of first-aiders:

Notes to physician:

In the case of accident or if you feel unwell, seek medical advice immediately.
When symptoms persist or in all cases of doubt seek medical
advice.
If inhaled, remove to fresh air.
Get medical attention.
In case of contact, immediately flush skin with soap and plentyof water.
Remove contaminated clothing and shoes.
Get medical attention.
Wash clothing before reuse.
Thoroughly clean shoes before reuse.
If in eyes, rinse well with water.
Get medical attention if irritation develops and persists.
If swallowed, DO NOT induce vomiting.
Get medical attention.
Rinse mouth thoroughly with water.
May cause cancer.
May damage fertility. May damage the unborn child.
Causes damage to organs through prolonged or repeatedexposure.
Contact with dust can cause mechanical irritation or drying of
the skin.
Dust contact with the eyes can lead to mechanical irritation.
First Aid responders should pay attention to self-protection,and use the recommended personal protective equipment
when the potential for exposure exists (see section 8).
Treat symptomatically and supportively.

5. FIREFIGHTING MEASURES
Suitable extinguishing media:

Water spray
Alcohol-resistant foam
Carbon dioxide (CO2)
Dry chemical
None known.

Unsuitable extinguishingmedia
Specific hazards during firefighting::

Avoid generating dust; fine dust dispersed in air in sufficientconcentrations, and in the presence of an ignition source is apotential dust explosion hazard.
Exposure to combustion products may be a hazard to health.

Hazardous combustion products:

Carbon oxides
Nitrogen oxides (NOx)Specific extinguishing methods:

Use extinguishing measures that are appropriate to local circumstances and the surrounding environment.
Use water spray to cool unopened containers.
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SAFETY DATA SHEET

Nomegestrol / Estradiol Formulation
Version
10.0

Revision Date:
2024/04/06

Special protective equipment
for firefighters

SDS Number:
17227-00024:

Date of last issue: 2023/09/26
Date of first issue: 2014/09/30

Remove undamaged containers from fire area if it is safe to doso.
Evacuate area.
In the event of fire, wear self-contained breathing apparatus.
Use personal protective equipment.

6. ACCIDENTAL RELEASE MEASURES
Personal precautions, protec- :tive equipment and emergency procedures

Use personal protective equipment.
Follow safe handling advice (see section 7) and personal protective equipment recommendations (see section 8).

Environmental precautions:

Avoid release to the environment.
Prevent further leakage or spillage if safe to do so.
Retain and dispose of contaminated wash water.
Local authorities should be advised if significant spillages
cannot be contained.

Methods and materials forcontainment and cleaning up:

Sweep up or vacuum up spillage and collect in suitable container for disposal.
Avoid dispersal of dust in the air (i.e., clearing dust surfaces
with compressed air).
Dust deposits should not be allowed to accumulate on surfaces, as these may form an explosive mixture if they are released into the atmosphere in sufficient concentration.
Local or national regulations may apply to releases and disposal of this material, as well as those materials and items
employed in the cleanup of releases. You will need to determine which regulations are applicable.
Sections 13 and 15 of this SDS provide information regarding
certain local or national requirements.

Handling
Technical measures:

Local/Total ventilation:

Advice on safe handling:

Static electricity may accumulate and ignite suspended dust
causing an explosion.
Provide adequate precautions, such as electrical grounding
and bonding, or inert atmospheres.
If sufficient ventilation is unavailable, use with local exhaust
ventilation.
Do not get on skin or clothing.
Do not breathe dust.
Do not swallow.
Avoid contact with eyes.
Wash skin thoroughly after handling.
Handle in accordance with good industrial hygiene and safety
practice, based on the results of the workplace exposure assessment
Keep container tightly closed.

7. HANDLING AND STORAGE

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SAFETY DATA SHEET

Nomegestrol / Estradiol Formulation
Version
10.0

Revision Date:
2024/04/06

SDS Number:
17227-00024

Avoidance of contact
Hygiene measures::

Storage
Conditions for safe storage:

Materials to avoid:

Packaging material:

Date of last issue: 2023/09/26
Date of first issue: 2014/09/30

Minimize dust generation and accumulation.
Keep container closed when not in use.
Keep away from heat and sources of ignition.
Take precautionary measures against static discharges.
Do not eat, drink or smoke when using this product.
Take care to prevent spills, waste and minimize release to theenvironment.
Oxidizing agents
If exposure to chemical is likely during typical use, provide eye
flushing systems and safety showers close to the working
place.
When using do not eat, drink or smoke.
Wash contaminated clothing before re-use.
Keep in properly labelled containers.
Store locked up.
Keep tightly closed.
Store in accordance with the particular national regulations.
Do not store with the following product types:
Strong oxidizing agents
Unsuitable material: None known.

8. EXPOSURE CONTROLS/PERSONAL PROTECTION
Threshold limit value and permissible exposure limits for each component in the work environment
Components

CAS-No.

Value type
(Form ofexposure)

Cellulose
Estradiol

9004-34-6
50-28-2

TWA
TWA

17-Hydroxy-6-methyl-19norpregna-4,6-diene-3,20dione 17-acetate
Talc

Further information: Skin
Wipe limit
58652-20-3
TWA

14807-96-6

5 / 25

Wipe limit
OEL-M(Respirable
particulatematter)OEL-M (Total
particulatematter)
TWA (Respirable par-Control parameters / Reference
concentration /Permissible concentration
10 mg/m3
0.05 µg/m3 (OEB
5)

Basis

0.5 µg/100 cm²
0.2 µg/m3

Internal
Internal

2 µg/100 cm²
1 mg/m3

Internal
JP OEL
JSOH

4 mg/m3

JP OEL
JSOH

2 mg/m3

ACGIH

ACGIH
Internal

SAFETY DATA SHEET

Nomegestrol / Estradiol Formulation
Version
10.0

Revision Date:
2024/04/06

SDS Number:
17227-00024

ticulate matter)
13463-67-7
OEL-M
1.5 mg/m3
JP OEL(Respirable(Titanium)
JSOH
particulatematter)Further information: Group 2B: possibly carcinogenic to humans
OEL-M (Total 2 mg/m3
JP OELparticulate(Titanium)
JSOH
matter)Further information: Group 2B: possibly carcinogenic to humans

Titanium dioxide

Engineering measures

Date of last issue: 2023/09/26
Date of first issue: 2014/09/30:

Minimize workplace exposure concentrations.
Apply measures to prevent dust explosions.
Ensure that dust-handling systems (such as exhaust ducts,
dust collectors, vessels, and processing equipment) are designed in a manner to prevent the escape of dust into thework area (i.e., there is no leakage from the equipment).
If sufficient ventilation is unavailable, use with local exhaust
ventilation.

Personal protective equipment
Respiratory protection: If adequate local exhaust ventilation is not available or exposure assessment demonstrates exposures outside the recommended guidelines, use respiratory protection.
Filter type
: Particulates type
Hand protection
Material:

Chemical-resistant gloves

Remarks:

Eye protection:

Skin and body protection:

Choose gloves to protect hands against chemicals dependingon the concentration and quantity of the hazardous substance and specific to place of work. Breakthrough time is notdetermined for the product. Change gloves often! For special
applications, we recommend clarifying the resistance tochemicals of the aforementioned protective gloves with theglove manufacturer. Wash hands before breaks and at theend of workday.
Wear the following personal protective equipment:
Safety goggles
Select appropriate protective clothing based on chemical
resistance data and an assessment of the local exposure
potential.
Skin contact must be avoided by using impervious protective
clothing (gloves, aprons, boots, etc).

9. PHYSICAL AND CHEMICAL PROPERTIES
Physical state:

powderColour:white

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SAFETY DATA SHEET

Nomegestrol / Estradiol Formulation
Version
10.0

Revision Date:
2024/04/06

SDS Number:
17227-00024

Date of last issue: 2023/09/26
Date of first issue: 2014/09/30

Odour

:

odourlessOdour Threshold:

No data available

Melting point/freezing point:

No data available

Boiling point, initial boilingpoint and boiling range:

No data available

Flammability (solid, gas):

May form explosive dust-air mixture during processing, handling or other means.

Flammability (liquids):

No data available

Lower explosion limit and upper explosion limit / flammability limit
Upper explosion limit / Up- : No data available
per flammability limit
Lower explosion limit /Lower flammability limit:

No data available

Flash point:

No data available

Decomposition temperature:

No data available

pH:

No data available

Evaporation rate:

No data available

Auto-ignition temperature:

No data available

Viscosity
Viscosity, dynamic:

No data available

Viscosity, kinematic:

No data available:

No data available

Partition coefficient: noctanol/water:

No data available

Vapour pressure:

No data available

Density and / or relative density
Relative density:

No data available

Solubility(ies)
Water solubility

Density:

1 g/cm³

Relative vapour density:

No data available

Explosive properties:

Not explosive
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SAFETY DATA SHEET

Nomegestrol / Estradiol Formulation
Version
10.0

Revision Date:
2024/04/06

SDS Number:
17227-00024

Date of last issue: 2023/09/26
Date of first issue: 2014/09/30

Oxidizing properties:

The substance or mixture is not classified as oxidizing.

Molecular weight:

No data available

Particle characteristics
Particle size:

No data available

Reactivity
Chemical stability
Possibility of hazardous reactions:::

Not classified as a reactivity hazard.
Stable under normal conditions.
May form explosive dust-air mixture during processing, handling or other means.
Can react with strong oxidizing agents.

Conditions to avoid:

Incompatible materials
Hazardous decomposition
products::

Heat, flames and sparks.
Avoid dust formation.
Oxidizing agents
No hazardous decomposition products are known.

10. STABILITY AND REACTIVITY

11. TOXICOLOGICAL INFORMATION
Information on likely routes of :exposure

Inhalation
Skin contact
Ingestion
Eye contact

Acute toxicity
Not classified based on available information.
Components:
Cellulose:
Acute oral toxicity:

LD50 (Rat): > 5,000 mg/kg

Acute inhalation toxicity:

LC50 (Rat): > 5.8 mg/l
Exposure time: 4 h
Test atmosphere: dust/mist

Acute dermal toxicity:

LD50 (Rabbit): > 2,000 mg/kg

Estradiol:
Acute oral toxicity:

LD50 (Rat): > 2,000 mg/kg

Acute toxicity (other routes of :administration)

LD50 (Rat): > 300 mg/kg
Application Route: Subcutaneous

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SAFETY DATA SHEET

Nomegestrol / Estradiol Formulation
Version
10.0

Revision Date:
2024/04/06

SDS Number:
17227-00024

Date of last issue: 2023/09/26
Date of first issue: 2014/09/30

17-Hydroxy-6-methyl-19-norpregna-4,6-diene-3,20-dione 17-acetate:
Acute oral toxicity: LD50 (Rat): > 2,000 mg/kg
LD50 (Mouse): > 2,000 mg/kg
Acute toxicity (other routes of :administration)

LD50 (Rat): > 2,000 mg/kg
Application Route: Intraperitoneal

Talc:
Acute oral toxicity:

LD50 (Rat): > 5,000 mg/kg
Remarks: Based on data from similar materials

Titanium dioxide:
Acute oral toxicity:

LD50 (Rat): > 5,000 mg/kg

Acute inhalation toxicity:

LC50 (Rat): > 6.82 mg/l
Exposure time: 4 h
Test atmosphere: dust/mist
Assessment: The substance or mixture has no acute inhalation toxicity

Propylene glycol:
Acute oral toxicity:

LD50 (Rat): 22,000 mg/kg

Acute inhalation toxicity:

LC50 (Rat): > 44.9 mg/l
Exposure time: 4 h
Test atmosphere: dust/mist

Acute dermal toxicity:

LD50 (Rabbit): > 2,000 mg/kg
Assessment: The substance or mixture has no acute dermal
toxicity

Skin corrosion/irritation
Not classified based on available information.
Components:
Talc:
SpeciesResult::RabbitNo skin irritation

Titanium dioxide:
SpeciesResult::RabbitNo skin irritation

Propylene glycol:
Species
Method::RabbitOECD Test Guideline 404
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Nomegestrol / Estradiol Formulation
Version
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Revision Date:
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ResultSDS Number:
17227-00024:

Date of last issue: 2023/09/26
Date of first issue: 2014/09/30

No skin irritation

Serious eye damage/eye irritation
Not classified based on available information.
Components:
Estradiol:
Result:No eye irritation

Talc:
SpeciesResult::RabbitNo eye irritation

Titanium dioxide:
SpeciesResult::RabbitNo eye irritation

Propylene glycol:
SpeciesResult
Method:::RabbitNo eye irritation
OECD Test Guideline 405

Respiratory or skin sensitisation
Skin sensitisation
Not classified based on available information.
Respiratory sensitisation
Not classified based on available information.
Components:
Estradiol:
Exposure routes
Species
Assessment
Result::::Skin contact
Guinea pig
Does not cause skin sensitisation.
negative

Talc:
Exposure routes
SpeciesResult:::Skin contact
Humansnegative

Titanium dioxide:
Test Type
Exposure routes
Species:::

Local lymph node assay (LLNA)
Skin contact
Mouse
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Version
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Revision Date:
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SDS Number:
17227-00024

Result:negative

Propylene glycol:
Test Type
Exposure routes
SpeciesResult::::Maximisation Test
Skin contact
Guinea pig
negative

Date of last issue: 2023/09/26
Date of first issue: 2014/09/30

Germ cell mutagenicity
Not classified based on available information.
Components:
Cellulose:
Genotoxicity in vitro:

Test Type: Bacterial reverse mutation assay (AMES)
Result: negative
Test Type: In vitro mammalian cell gene mutation test
Result: negative

Genotoxicity in vivo:

Test Type: Mammalian erythrocyte micronucleus test (in vivo
cytogenetic assay)
Species: Mouse
Application Route: Ingestion
Result: negative

Estradiol:
Genotoxicity in vitro:

Test Type: DNA damage and repair, unscheduled DNA synthesis in mammalian cells (in vitro)
Test system: mammalian cells
Result: positive
Test Type: Chromosome aberration test in vitro
Test system: mammalian cells
Result: positive
Test Type: Chromosomal aberration
Test system: mammalian cells
Result: positive

Genotoxicity in vivo:

Test Type: Chromosomal aberration
Species: Rat
Cell type: Bone marrow
Result: negative
Test Type: Chromosomal aberration
Species: Mouse
Cell type: Bone marrow
Result: negative

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SAFETY DATA SHEET

Nomegestrol / Estradiol Formulation
Version
10.0

Revision Date:
2024/04/06

SDS Number:
17227-00024

Date of last issue: 2023/09/26
Date of first issue: 2014/09/30

17-Hydroxy-6-methyl-19-norpregna-4,6-diene-3,20-dione 17-acetate:
Genotoxicity in vitro: Test Type: Ames test
Result: negative
Test Type: Chromosome aberration test in vitro
Result: negative
Test Type: DNA damage and repair, unscheduled DNA synthesis in mammalian cells (in vitro)
Result: negative
Test Type: In vitro mammalian cell gene mutation test
Result: negative
Genotoxicity in vivo:

Test Type: In vivo micronucleus test
Species: Rat
Application Route: Oral
Result: negative
Test Type: In vivo micronucleus test
Species: Mouse
Application Route: Oral
Result: negative

Talc:
Genotoxicity in vitro:

Test Type: DNA damage and repair, unscheduled DNA synthesis in mammalian cells (in vitro)
Result: negative

Genotoxicity in vivo:

Test Type: Chromosome aberration test in vitro
Species: Rat
Application Route: Ingestion
Result: negative

Titanium dioxide:
Genotoxicity in vitro:

Test Type: Bacterial reverse mutation assay (AMES)
Result: negative

Genotoxicity in vivo:

Test Type: In vivo micronucleus test
Species: Mouse
Result: negative

Propylene glycol:
Genotoxicity in vitro:

Test Type: Bacterial reverse mutation assay (AMES)
Result: negative
Test Type: Chromosome aberration test in vitro
Method: OECD Test Guideline 473
Result: negative

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Version
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Genotoxicity in vivo

SDS Number:
17227-00024

Date of last issue: 2023/09/26
Date of first issue: 2014/09/30:

Test Type: Mammalian erythrocyte micronucleus test (in vivo
cytogenetic assay)
Species: Mouse
Application Route: Intraperitoneal injection
Result: negative

Cellulose:
Species
Application RouteExposure time
Result

:
:
:
:

Rat
Ingestion
72 weeks
negative

Estradiol:
Species
Application RouteExposure time
LOAEL
ResultTarget Organs

:
:
:
:
:
:

Mouse
Ingestion
24 Months
100 µg/kg
positive
female reproductive organs

Species
Application RouteExposure time
LOAEL
ResultTarget Organs

:
:
:
:
:
:

Rat
Subcutaneous
13 weeks
20 mg/kg body weight
positive
Endocrine system

Carcinogenicity - Assessment:

Positive evidence from human epidemiological studies

Carcinogenicity
May cause cancer.
Components:

17-Hydroxy-6-methyl-19-norpregna-4,6-diene-3,20-dione 17-acetate:
Species: Rat
Application Route: oral (feed)
Activity duration: 52 Weeks: 10 mg/kg body weight
Result: negative
Species
Application Route
ResultTarget Organs
Carcinogenicity - Assessment

:
:
:
:
:

Mouse
oral (feed)
20 mg/kg body weight
positive
Mammary gland, Pituitary gland:

Weight of evidence does not support classification as a carcinogen

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Nomegestrol / Estradiol Formulation
Version
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Revision Date:
2024/04/06

SDS Number:
17227-00024

Date of last issue: 2023/09/26
Date of first issue: 2014/09/30

Talc:
Species
Application RouteExposure time
Result

:
:
:
:

Mouse
inhalation (dust/mist/fume)
2 Years
negative

Titanium dioxide:
Species
Application RouteExposure time
MethodResultRemarks

:
:
:
:
:
:

Rat
inhalation (dust/mist/fume)
2 Years
OECD Test Guideline 453
positive
The mechanism or mode of action may not be relevant in
humans.

:Limited evidence of carcinogenicity in inhalation studies withanimals.

:
:
:
:

Rat
Ingestion
2 Years
negative

Carcinogenicity - Assessment
Propylene glycol:
Species
Application RouteExposure time
ResultReproductive toxicity
May damage fertility. May damage the unborn child.
Components:
Cellulose:
Effects on fertility

Effects on foetal development

Estradiol:
Effects on fertility:

Test Type: One-generation reproduction toxicity study
Species: Rat
Application Route: Ingestion
Result: negative:

Test Type: Fertility/early embryonic development
Species: Rat
Application Route: Ingestion
Result: negative:

Test Type: One-generation reproduction toxicity study
Species: Rat
Application Route: Ingestion
Fertility: LOAEL: 0.5 mg/kg body weight
Result: Effects on fertility
Test Type: One-generation reproduction toxicity study
Species: Rat
Duration of Single Treatment: 90 d
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Revision Date:
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SDS Number:
17227-00024

Date of last issue: 2023/09/26
Date of first issue: 2014/09/30

Fertility: LOAEL: 0.69 mg/kg body weight
Result: Effects on fertility
Test Type: Two-generation study
Species: Mouse
Application Route: Oral
Fertility: LOAEL: 0.1 mg/kg body weight
Result: Effects on fertility
Effects on foetal development:

Test Type: Embryo-foetal development
Species: Mouse, female
Application Route: Subcutaneous
Teratogenicity: LOAEL: 4 mg/kg body weight
Symptoms: Malformations were observed.
Result: positive, Teratogenic effects
Test Type: One-generation reproduction toxicity study
Species: Rat
Application Route: Subcutaneous
Teratogenicity: LOAEL: 2.5 µg/kg body weight
Symptoms: Reduced body weight
Result: positive, Embryotoxic effects and adverse effects on
the offspring were detected.
Test Type: Embryo-foetal development
Species: Rat
Application Route: Subcutaneous
Developmental Toxicity: LOAEL: 0.2 mg/kg body weight
Symptoms: Early Resorptions / resorption rate, Reduced
number of viable fetuses, Reduced body weight
Result: Embryotoxic effects and adverse effects on the offspring were detected only at high maternally toxic doses

Reproductive toxicity - Assessment:

May damage fertility. May damage the unborn child.

17-Hydroxy-6-methyl-19-norpregna-4,6-diene-3,20-dione 17-acetate:
Effects on foetal develop: Test Type: Development
ment
Species: Rat
Application Route: Oral
Result: negative
Test Type: Embryo-foetal development
Species: Rabbit
Application Route: Oral
Result: negative, No teratogenic effects
Reproductive toxicity - Assessment
Talc:
Effects on foetal develop-:

Positive evidence of adverse effects on sexual function andfertility from human epidemiological studies.

:

Test Type: Embryo-foetal development
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Revision Date:
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SDS Number:
17227-00024

ment

Propylene glycol:
Effects on fertility

Effects on foetal development

Date of last issue: 2023/09/26
Date of first issue: 2014/09/30

Species: Rat
Application Route: Ingestion
Result: negative:

Test Type: Two-generation reproduction toxicity study
Species: Mouse
Application Route: Ingestion
Result: negative:

Test Type: Embryo-foetal development
Species: Mouse
Application Route: Ingestion
Result: negative

STOT - single exposure
Not classified based on available information.
STOT - repeated exposure
Causes damage to organs (Liver, Bone, Blood, Endocrine system) through prolonged or repeatedexposure.
Components:
Estradiol:
Target Organs
Assessment::

Liver, Bone, Blood, Endocrine system
Causes damage to organs through prolonged or repeatedexposure.

Cellulose:
Species
NOAEL
Application RouteExposure time

:
:
:
:

Rat
>= 9,000 mg/kg
Ingestion
90 Days

Estradiol:
Species
LOAEL
Application RouteExposure timeTarget Organs

:
:
:
:
:

Rat
>= 0.17 mg/kg
Ingestion
90 d
Mammary gland, Ovary, Uterus (including cervix), Liver, Bone,
Endocrine system, Blood, Testis

Repeated dose toxicity
Components:

17-Hydroxy-6-methyl-19-norpregna-4,6-diene-3,20-dione 17-acetate:
Species: MouseNOAEL: 20 mg/kg
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Revision Date:
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SDS Number:
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Date of last issue: 2023/09/26
Date of first issue: 2014/09/30

Application RouteExposure time

:
:

Oral
52 Weeks

Species
NOAEL
Application RouteExposure time

:
:
:
:

Rat
20 mg/kg
Oral
52 Weeks

Titanium dioxide:
Species
NOAEL
Application RouteExposure time

:
:
:
:

Rat
24,000 mg/kg
Ingestion
28 DaysSpecies
NOAEL
Application RouteExposure time

:
:
:
:

Rat
10 mg/m3
inhalation (dust/mist/fume)
2 yr

Propylene glycol:
Species
NOAEL
Application RouteExposure time

:
:
:
:

Rat, male>= 1,700 mg/kg
Ingestion
2 yr

Aspiration toxicity
Not classified based on available information.
Experience with human exposure
Components:
Estradiol:
Inhalation:

Symptoms: tingling, Nose bleeding

Skin contact:

Symptoms: Skin irritation, Redness, pruritis

Ingestion:

Symptoms: Headache, Gastrointestinal disturbance, Dizziness, Vomiting, Diarrhoea, water retention, liver functionchange, changes in libido, breast tenderness, menstrual irregularities

17-Hydroxy-6-methyl-19-norpregna-4,6-diene-3,20-dione 17-acetate:Ingestion: Symptoms: acne, amenorhea, Headache, Dizziness, Nausea,
breast tenderness, changes in libido, insomnia, musculoskeletal pain, mood swings, muscle pain, muscle twitching

17 / 25

SAFETY DATA SHEET

Nomegestrol / Estradiol Formulation
Version
10.0

Revision Date:
2024/04/06

SDS Number:
17227-00024

Date of last issue: 2023/09/26
Date of first issue: 2014/09/30

12. ECOLOGICAL INFORMATION
Ecotoxicity
Components:
Cellulose:
Toxicity to fish:

LC50 (Oryzias latipes (Japanese medaka)): > 100 mg/l
Exposure time: 48 h
Remarks: Based on data from similar materials

Estradiol:
Toxicity to fish:

LC50 (Oryzias latipes (Japanese medaka)): 3.9 mg/l
Exposure time: 96 h

Toxicity to daphnia and otheraquatic invertebrates:

EC50 (Daphnia magna (Water flea)): 2.7 mg/l
Exposure time: 48 h

Toxicity to algae/aquaticplants:NOEC (Pseudokirchneriella subcapitata (green algae)): 1.7
mg/l
Exposure time: 72 h
Method: OECD Test Guideline 201
EC50 (Pseudokirchneriella subcapitata (green algae)): > 1.7
mg/l
Exposure time: 72 h
Method: OECD Test Guideline 201

Toxicity to fish (Chronic toxicity):

Toxicity to daphnia and other :aquatic invertebrates (Chronic toxicity)
M-Factor (Chronic aquatic:
toxicity)
Toxicity to microorganisms:

NOEC (Oryzias latipes (Japanese medaka)): 0.000003 mg/l
Exposure time: 160 d
Method: OECD Test Guideline 210
NOEC (Daphnia magna (Water flea)): 0.2 mg/l
Exposure time: 21 d
1,000
EC50: > 100 mg/l
Exposure time: 3 hTest Type: Respiration inhibition
Method: OECD Test Guideline 209
NOEC: 100 mg/l
Exposure time: 3 hTest Type: Respiration inhibition
Method: OECD Test Guideline 209

17-Hydroxy-6-methyl-19-norpregna-4,6-diene-3,20-dione 17-acetate:
Toxicity to algae/aquatic: EC50 (Pseudokirchneriella subcapitata (green algae)): > 3.07
plantsmg/l
18 / 25

SAFETY DATA SHEET

Nomegestrol / Estradiol Formulation
Version
10.0

Revision Date:
2024/04/06

SDS Number:
17227-00024

Date of last issue: 2023/09/26
Date of first issue: 2014/09/30

Exposure time: 72 h
Method: OECD Test Guideline 201
NOEC (Pseudokirchneriella subcapitata (green algae)): 0.69
mg/l
Exposure time: 72 h
Method: OECD Test Guideline 201
Toxicity to fish (Chronic toxicity):

NOEC (Zebrafish): 0.0013 mg/l
Exposure time: 27 d

Toxicity to daphnia and other :aquatic invertebrates (Chronic toxicity)

NOEC (Daphnia magna (Water flea)): 3.65 mg/l
Exposure time: 21 d
Method: OECD Test Guideline 211
Remarks: No toxicity at the limit of solubility

M-Factor (Chronic aquatic
toxicity)
Toxicity to microorganisms

:

10

:

EC50 (Natural microorganism): > 2.8 mg/l
Exposure time: 3 hTest Type: Respiration inhibition
Method: OECD Test Guideline 209
NOEC (Natural microorganism): 2.8 mg/l
Exposure time: 3 hTest Type: Respiration inhibition
Method: OECD Test Guideline 209
Remarks: No toxicity at the limit of solubility

Talc:
Toxicity to fish:

LC50 (Brachydanio rerio (zebrafish)): > 100,000 mg/l
Exposure time: 24 h

Titanium dioxide:
Toxicity to fish:

LC50 (Oncorhynchus mykiss (rainbow trout)): > 100 mg/l
Exposure time: 96 h
Method: OECD Test Guideline 203

Toxicity to daphnia and otheraquatic invertebrates:

EC50 (Daphnia magna (Water flea)): > 100 mg/l
Exposure time: 48 h

Toxicity to algae/aquaticplants:

EC50 (Skeletonema costatum (marine diatom)): > 10,000 mg/l
Exposure time: 72 h

Toxicity to microorganisms:

EC50: > 1,000 mg/l
Exposure time: 3 hMethod: OECD Test Guideline 209

Propylene glycol:
Toxicity to fish:

LC50 (Oncorhynchus mykiss (rainbow trout)): 40,613 mg/l
19 / 25

SAFETY DATA SHEET

Nomegestrol / Estradiol Formulation
Version
10.0

Revision Date:
2024/04/06

SDS Number:
17227-00024

Date of last issue: 2023/09/26
Date of first issue: 2014/09/30

Exposure time: 96 h
Toxicity to daphnia and otheraquatic invertebrates:

EC50 (Ceriodaphnia dubia (water flea)): 18,340 mg/l
Exposure time: 48 h

Toxicity to algae/aquaticplants:

ErC50 (Skeletonema costatum (marine diatom)): 19,300 mg/l
Exposure time: 72 h
Method: OECD Test Guideline 201

Toxicity to daphnia and other :aquatic invertebrates (Chronic toxicity)
Toxicity to microorganisms:

NOEC (Ceriodaphnia dubia (water flea)): 13,020 mg/l
Exposure time: 7 d
NOEC (Pseudomonas putida): > 20,000 mg/l
Exposure time: 18 h

Persistence and degradability
Components:
Cellulose:
Biodegradability:

Result: Readily biodegradable.

Estradiol:
Biodegradability:

Result: rapidly degradable
Biodegradation: 84 %Exposure time: 24 hrs

Propylene glycol:
Biodegradability:

Result: Readily biodegradable.
Biodegradation: 98.3 %Exposure time: 28 d
Method: OECD Test Guideline 301F:

log Pow: 4.01

Bioaccumulative potential
Components:
Estradiol:
Partition coefficient: noctanol/water

17-Hydroxy-6-methyl-19-norpregna-4,6-diene-3,20-dione 17-acetate:
Bioaccumulation: Species: Zebrafish
Bioconcentration factor (BCF): 44
Partition coefficient: noctanol/water
Propylene glycol:
Partition coefficient: noctanol/water:log Pow: 3.7:

log Pow: -1.07
Method: Regulation (EC) No. 440/2008, Annex, A.8
20 / 25

SAFETY DATA SHEET

Nomegestrol / Estradiol Formulation
Version
10.0

Revision Date:
2024/04/06

SDS Number:
17227-00024

Date of last issue: 2023/09/26
Date of first issue: 2014/09/30

Mobility in soil
Components:
Estradiol:
Distribution among environmental compartments:

log Koc: 3.81

17-Hydroxy-6-methyl-19-norpregna-4,6-diene-3,20-dione 17-acetate:
Distribution among environ: log Koc: 3.35
mental compartments
Method: OECD Test Guideline 106
Hazardous to the ozone layer
Not applicable
Other adverse effects
No data available
13. DISPOSAL CONSIDERATIONS
Disposal methods
Waste from residues:

Contaminated packaging:

Dispose of in accordance with local regulations.
Do not dispose of waste into sewer.
Empty containers should be taken to an approved waste handling site for recycling or disposal.
If not otherwise specified: Dispose of as unused product.

14. TRANSPORT INFORMATIONInternational Regulations
UNRTDGUN number
Proper shipping name

:
:

Class
Packing group
LabelsEnvironmentally hazardous

:
:
:
:

IATA-DGR
UN/ID No.
Proper shipping name

:
:

Class
Packing group
Labels:::UN 3077
ENVIRONMENTALLY HAZARDOUS SUBSTANCE, SOLID,
N.O.S.
(Estradiol, 17-Hydroxy-6-methyl-19-norpregna-4,6-diene3,20-dione 17-acetate)
9
III
9
yes
UN 3077
Environmentally hazardous substance, solid, n.o.s.
(Estradiol, 17-Hydroxy-6-methyl-19-norpregna-4,6-diene3,20-dione 17-acetate)
9
III
Miscellaneous
21 / 25

SAFETY DATA SHEET

Nomegestrol / Estradiol Formulation
Version
10.0

Revision Date:
2024/04/06

Packing instruction (cargo
aircraft)Packing instruction (passenger aircraft)
Environmentally hazardous

SDS Number:
17227-00024

Date of last issue: 2023/09/26
Date of first issue: 2014/09/30

:

956

:

956

:

yes

IMDG-CodeUN number
Proper shipping name

:
:

Class
Packing group
LabelsEmS Code
Marine pollutant

:
:
:
:
:

UN 3077
ENVIRONMENTALLY HAZARDOUS SUBSTANCE, SOLID,
N.O.S.
(Estradiol, 17-Hydroxy-6-methyl-19-norpregna-4,6-diene-3,20dione 17-acetate)
9III
9F-A, S-F
yes

Transport in bulk according to Annex II of MARPOL 73/78 and the IBC CodeNot applicable for product as supplied.
National Regulations
Refer to section 15 for specific national regulation.
Special precautions for user
The transport classification(s) provided herein are for informational purposes only, and solely
based upon the properties of the unpackaged material as it is described within this Safety Data
Sheet. Transportation classifications may vary by mode of transportation, package sizes, and variations in regional or country regulations.
ERG Code:171

15. REGULATORY INFORMATION
Related Regulations
Fire Service Law
Not applicable to dangerous materials / designated flammables.
Chemical Substance Control Law
Priority Assessment Chemical SubstanceChemical namePropane-1,2-diol

Number106

Industrial Safety and Health Law
Harmful Substances Prohibited from Manufacture
Not applicable
Harmful Substances Required Permission for Manufacture
Not applicable
Substances Prevented From Impairment of Health
Not applicable
22 / 25

SAFETY DATA SHEET

Nomegestrol / Estradiol Formulation
Version
10.0

Revision Date:
2024/04/06

SDS Number:
17227-00024

Date of last issue: 2023/09/26
Date of first issue: 2014/09/30

Circular concerning Information on Chemicals having Mutagenicity - Annex 2: Information
on Existing Chemicals having Mutagenicity
Not applicable
Circular concerning Information on Chemicals having Mutagenicity - Annex 1: Information
on Notified Substances having Mutagenicity
Not applicable
Substances Subject to be Notified Names
Article 57-2 (Enforcement Order Table 9)
Chemical nameTalc (Mg3H2(SiO3)4) (without asbestos
and quartz)
Titanium(IV) oxide

Concentration (%)>0 - <10

Remarks
From April 1st, 2025

>0 - <10-

Substances Subject to be Indicated Names
Article 57 (Enforcement Order Article 18)
Chemical nameTalc (Mg3H2(SiO3)4)Remarks
From April 1st, 2025

Carcinogenic Substances (Article 577-2 of the Occupational Health and Safety Regulations)Not applicable
Ordinance on Prevention of Hazards Due to Specified Chemical Substances
Not applicable
Ordinance on Prevention of Lead Poisoning
Not applicable
Ordinance on Prevention of Tetraalkyl Lead Poisoning
Not applicable
Ordinance on Prevention of Organic Solvent Poisoning
Not applicable
Enforcement Order of the Industrial Safety and Health Law - Attached table 1 (Dangerous
Substances)
Not applicable
Poisonous and Deleterious Substances Control Law
Not applicable
Act on Confirmation, etc. of Release Amounts of Specific Chemical Substances in the Environment and Promotion of Improvements to the Management Thereof
Not applicable
High Pressure Gas Safety Act
Not applicable
Explosive Control Law
Not applicable

23 / 25

SAFETY DATA SHEET

Nomegestrol / Estradiol Formulation
Version
10.0

Revision Date:
2024/04/06

SDS Number:
17227-00024

Date of last issue: 2023/09/26
Date of first issue: 2014/09/30

Vessel Safety Law
Miscellaneous dangerous substances and articles (Article 2 and 3 of rules on shipping and storage of dangerous goods and its Attached Table 1)
Aviation Law
Miscellaneous dangerous substances and articles (Article 194 of The Enforcement Rules of Aviation Law and its Attached Table 1)
Marine Pollution and Sea Disaster Prevention etc Law
Bulk transportation:

Not classified as noxious liquid substance

Pack transportation:

Classified as marine pollutant

Narcotics and Psychotropics Control Act
Narcotic or Psychotropic Raw Material (Export / Import Permission)
Not applicableSpecific Narcotic or Psychotropic Raw Material (Export / Import permission)
Not applicable
Waste Disposal and Public Cleansing Law
Industrial waste
The components of this product are reported in the following inventories:
AICS: not determinedDSL:

not determined

IECSC

:

not determined

16. OTHER INFORMATIONIn this SDS, if the concentration of substances subject to notification under the Industrial Safety
and Health Law is indicated as a range, it includes cases where it is a trade secret.
Further information
Sources of key data used tocompile the Safety Data
Sheet

:

Internal technical data, data from raw material SDSs, OECD
eChem Portal search results and European Chemicals Agency, http://echa.europa.eu/

Items where changes have been made to the previous version are highlighted in the body of thisdocument by two vertical lines.
Date format:

yyyy/mm/dd

Full text of other abbreviations
ACGIH: USA. ACGIH Threshold Limit Values (TLV)
JP OEL JSOH
: Japan. The Japan Society for Occupational Health. Recommendation of Occupational Exposure Limits
ACGIH / TWA
JP OEL JSOH / OEL-M::

8-hour, time-weighted average
Occupational Exposure Limit-Mean

24 / 25

SAFETY DATA SHEET

Nomegestrol / Estradiol Formulation
Version
10.0

Revision Date:
2024/04/06

SDS Number:
17227-00024

Date of last issue: 2023/09/26
Date of first issue: 2014/09/30

AIIC - Australian Inventory of Industrial Chemicals; ANTT - National Agency for Transport byLand of Brazil; ASTM - American Society for the Testing of Materials; bw - Body weight; CMR Carcinogen, Mutagen or Reproductive Toxicant; DIN - Standard of the German Institute forStandardisation; DSL - Domestic Substances List (Canada); ECx - Concentration associated with
x% response; ELx - Loading rate associated with x% response; EmS - Emergency Schedule;
ENCS - Existing and New Chemical Substances (Japan); ErCx - Concentration associated with
x% growth rate response; ERG - Emergency Response Guide; GHS - Globally Harmonized System; GLP - Good Laboratory Practice; IARC - International Agency for Research on Cancer; IATA
- International Air Transport Association; IBC - International Code for the Construction andEquipment of Ships carrying Dangerous Chemicals in Bulk; IC50 - Half maximal inhibitory concentration; ICAO - International Civil Aviation Organization; IECSC - Inventory of Existing Chemical Substances in China; IMDG - International Maritime Dangerous Goods; IMO - International
Maritime Organization; ISHL - Industrial Safety and Health Law (Japan); ISO - International Organisation for Standardization; KECI - Korea Existing Chemicals Inventory; LC50 - Lethal Concentration to 50 % of a test population; LD50 - Lethal Dose to 50% of a test population (Median
Lethal Dose); MARPOL - International Convention for the Prevention of Pollution from Ships;
n.o.s. - Not Otherwise Specified; Nch - Chilean Norm; NO(A)EC - No Observed (Adverse) EffectConcentration; NO(A)EL - No Observed (Adverse) Effect Level; NOELR - No Observable EffectLoading Rate; NOM - Official Mexican Norm; NTP - National Toxicology Program; NZIoC - New
Zealand Inventory of Chemicals; OECD - Organization for Economic Co-operation and Development; OPPTS - Office of Chemical Safety and Pollution Prevention; PBT - Persistent, Bioaccumulative and Toxic substance; PICCS - Philippines Inventory of Chemicals and Chemical Substances; (Q)SAR - (Quantitative) Structure Activity Relationship; REACH - Regulation (EC) No
1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals; SADT - Self-Accelerating Decomposition Temperature; SDS - Safety Data Sheet; TCSI - Taiwan Chemical Substance Inventory; TDG - Transportation of Dangerous Goods; TECI - Thailand Existing Chemicals Inventory; TSCA - Toxic Substances Control Act (United States); UN - United Nations; UNRTDG - United Nations Recommendations on the Transport of Dangerous Goods; vPvB - Very Persistent and Very Bioaccumulative; WHMIS - Workplace Hazardous Materials Information System
The information provided in this Safety Data Sheet is correct to the best of our knowledge, information and belief at the date of its publication. The information is designed only as a guidance forsafe handling, use, processing, storage, transportation, disposal and release and shall not be
considered a warranty or quality specification of any type. The information provided relates only
to the specific material identified at the top of this SDS and may not be valid when the SDS material is used in combination with any other materials or in any process, unless specified in the text.
Material users should review the information and recommendations in the specific context of theirintended manner of handling, use, processing and storage, including an assessment of the appropriateness of the SDS material in the user’s end product, if applicable.
JP / EN

25 / 25